Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus

Pfizer

Status and phase: Completed; Phase 2

Conditions: Diabetes, Type 2

Treatments: Drug: 450 mg PF-04991532; Drug: Sitagliptin 100 mg; Drug: 750 mg PF-04991532; Drug: 150 mg PF-04991532; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01336738

B2611002

Details and patient eligibility

About

B2611002 is designed to study how safe and effective an investigational medication (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 5 treatments for 3 months. One of the treatments will be sitagliptin which is an approved drug, and another treatment will be placebo, which does not contain active ingredient.

Enrollment: 266 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects with type 2 diabetes on stable doses of background medicines for management of diabetes; aged 18-70 years; body mass index between 22.5 and 45.5 kg/m2

Exclusion criteria

Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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266 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Matching placebo for PF-04991532 and Sitagliptin

Treatment:

Drug: Placebo

150 mg PF-04991532

Experimental group

Treatment:

Drug: 150 mg PF-04991532

450 mg PF-04991532

Experimental group

Treatment:

Drug: 450 mg PF-04991532

750 mg PF-04991532

Experimental group

Treatment:

Drug: 750 mg PF-04991532

Sitagliptin 100 mg

Active Comparator group

Treatment:

Drug: Sitagliptin 100 mg